DepressionNCT07806864
An Ultra-Brief ICBT Intervention: The 'Things You Do' Program
A study testing Things You Do Program (Ultra-Brief ICBT) and Things You Do Program Plus Personalized Feedback in people with Depression and Anxiety, run by University of Regina at 1 site in Canada.
Trial summary
Research shows that the single lesson 'Things You Do' Intervention is effective in increasing engagement in everyday healthy actions. However, no research has examined whether its effectiveness is enhanced by incorporating personalized feedback on participants' current level of engagement in healthy actions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Things You Do Program (Ultra-Brief ICBT) and Things You Do Program Plus Personalized Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 11 Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Canadian resident;
- Aged 18 years or older;
- Access to a computer (or another appropriate device) and the Internet;
- Willingness to learn information and skills to self-manage mental health difficulties.
Who cannot join
- Unable to read and understand English (All content is provided in English ).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Online Therapy Unit
Regina, Saskatchewan, S4S0A2
Marcie Nugent, 306-337-3331, marcie.nugent@uregina.ca
About this study
Official title: Understanding Engagement and Effectiveness of the 'Things You Do' Program
Research shows that the single lesson 'Things You Do' Intervention is effective in increasing engagement in everyday healthy actions. However, no research has examined whether its effectiveness is enhanced by incorporating personalized feedback on participants' current level of engagement in healthy actions. In this randomized controlled trial, clients will be randomly assigned to either receive or not receive personalized feedback informing them of their level of engagement in healthy actions over the previous week and encouraging them to participate in more healthy activities. The investigators will examine whether this feedback increases engagement in healthy actions and enhances the effectiveness of the 'Things You Do' Intervention as assessed through changes in primary outcomes.
Read the detailed description
Individuals seeking psychological services for mental health concerns often face barriers to care, including long wait times, cost, stigma, time constraints, geographical limitations, and difficulty accessing culturally sensitive providers. To address these barriers, Internet-delivered Cognitive Behavioral Therapy (ICBT) has emerged as a scalable, cost-effective, and accessible alternative to face-to-face therapy for individuals experiencing depression and anxiety. ICBT typically involves the delivery of evidence-based cognitive behavioral therapy through online lesson modules over several weeks or months, often accompanied by therapist support through secure messaging and/or telephone calls. However, research suggests that clients are satisfied with and benefit from brief forms of ICBT that require little to no therapist involvement.
In Saskatchewan, the Online Therapy Unit provides ICBT as part of routine care for a range of mental health concerns. Recently, the Unit introduced the Things You Do (TYD) program, a brief ICBT intervention for depression and anxiety that serves as an alternative to the standard 8-week ICBT program. The TYD program consists of a single lesson designed to reduce symptoms of depression and anxiety and further encourages engagement in everyday healthy actions via daily messaging, referred to as the 'Things You Do'. These healthy actions are organized into five domains: healthy thinking, meaningful activities, goals and plans, healthy routines, and social connections. Research indicates that greater engagement in these healthy actions is associated with lower levels of depression and anxiety, as well as improved overall mental health and well-being. The feasibility, acceptability, and effectiveness of the TYD program in routine care have also yielded promising results in a previous study conducted within the OTU. For instance, the results from this study indicated a significant increase in each of the healthy actions over time. While increased engagement in healthy actions was associated with reductions in anxiety and depressive symptoms, there are still opportunities to improve outcomes by assessing the effects of further personalizing the intervention on the outcomes. Although the TYD program provides information and strategies to encourage engagement in healthy actions, providing participants with personalized feedback regarding their current level of engagement may further enhance behavior change.
Research has demonstrated that personalized feedback can increase individuals' awareness of their own behaviours, facilitate behaviour change in targeted areas, and contribute to improved outcomes. In addition, personalized feedback has been associated with greater treatment satisfaction. Although personalized feedback has demonstrated benefits in areas such as alcohol misuse and pain management, its potential to promote engagement in healthy actions associated with mental health and well-being has not yet been examined. Providing clients with personalized feedback may increase awareness of their areas of strength, identify opportunities for improvement, and offer suggestions for increasing engagement in healthy behaviours.
The objective of the current study is to examine whether providing personalized feedback based on participants' reported frequency of engaging in healthy actions would encourage greater participation in healthy actions and enhance engagement in the TYD program. Participants will complete outcome measures at screening, Week 3, and Week 5. Primary outcomes include symptoms of depression, symptoms of anxiety, and engagement in healthy actions.
Randomization
Clients within a naturalistic online ICBT clinic eligible for the TYD program will be randomly assigned in a 1:1 ratio, using the REDCap randomization module, to either receive the standard TYD program or the standard program plus personalized feedback. The personalized feedback reports, developed using participants' responses to the Things You Do Questionnaire (TYDQ-15), are intended to increase awareness of areas of strength, identify areas for improvement, and provide suggestions for increasing engagement in healthy actions. Clients assigned to the personalized feedback condition will receive feedback at screening, in Week 3, and in Week 5 following completion of the TYDQ-15 at each assessment point.
- Conditions
- Depression, Anxiety
- Being tested
- Things You Do Program (Ultra-Brief ICBT), Things You Do Program Plus Personalized Feedback
- Keywords
- Depression, Anxiety, Personalized Feedback, Healthy Actions, Randomized Controlled Trial, Internet-delivered Cognitive Behavioral Therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Things You Do Program (Ultra-Brief ICBT)Behavioural
The TYD program is an ultra-brief ICBT intervention developed at Macquarie University, Australia. The intervention provides psychoeducation on mental health and five areas of healthy actions, known as the "Things You Do," along with practical skills to support engagement in these actions. These five areas include Meaningful Activities, Healthy Thinking, Goals and Plans, Healthy Habits, and Social Connections. The intervention includes a single lesson, a Weekly Planner, an Activity Guide, and a daily 'Tip of the Day' Offered for 30 days. The lesson content is presented across 25 slides using text and infographics and requires approximately 30-60 minutes to review. A key component of the TYD intervention is the daily 'Tip of the Day.' These are daily messages that clients receive for 30 days following the start of the intervention. Each message provides a tip or suggests a healthy action that clients can engage in that day. Clients complete the program without therapist support.
Things You Do Program Plus Personalized FeedbackBehavioural
Participants in this arm receive the same Things You Do (TYD) intervention as those in the comparative arm, with the addition of personalized feedback report. The TYD program is an ultra-brief ICBT intervention providing psychoeducation on mental health and five areas of healthy actions: Meaningful Activities, Healthy Thinking, Goals and Plans, Healthy Habits, and Social Connections. The intervention includes a single lesson (25 slides), Weekly Planner, Activity Guide, and daily "Tip of the Day" delivered for 30 days following enrollment in the intervention. Participants complete the intervention independently without therapist support. In addition to the standard TYD intervention, participants in this arm receive a personalized feedback report at screening, in Week 3, and in Week 5 following enrollment. Reports provide individualized feedback on participants' engagement across the five areas of healthy actions and are intended to encourage and motivate engagement in these areas.
| Study group | Role | What they receive |
|---|---|---|
| ICBT Without Personalized Feedback | Active comparator | At intake, clients eligible for the Things You Do (TYD) program will be randomly assigned (1:1 ratio) to either the Feedback Group or the No Feedback Group following completion of the demographic questionnaire, which includes the 15-item Things You Do Questionnaire. Clients will be automatically randomized using the Research Electronic Data Capture (REDCap) automated randomization module. Clients randomized to the No Feedback Group will receive the standard TYD intervention. All clients will complete the standardized questionnaires again in Weeks 3 and 5 following enrollments in the program. Receives: Behavioral: Things You Do Program (Ultra-Brief ICBT) |
| ICBT With Personalized Feedback | Experimental | Clients randomly assigned to the Feedback Group will receive the standard Things You Do (TYD) program as well as a personalized feedback report at intake, in Week 3, and in Week 5 following the completion of questionnaires at each of these time points. These personalized feedback reports are generated based on clients' scores on the Things You Do Questionnaire at each assessment time point. The reports are designed to inform clients of their level of engagement in healthy actions across the five areas of healthy actions. The reports highlight areas of strength and areas for improvement and provide encouragement and practical suggestions for increasing engagement in the areas in which clients reported the lowest levels of engagement. Receives: Behavioral: Things You Do Program Plus Personalized Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Things You Do-15 (TYD-15)
A measure of engagement in healthy actions over the previous week. 15 items are measured on a 5-point Likert scale ranging from 0-4. Subscales include Routine, Thoughts, Social, Activity, and Goals. Scores are summed into subscale scores ranging from 0 to 12, with a total score ranging from 0 to 60. Higher scores on this measure indicate greater engagement in healthy actions.
Measured: Baseline (intake), week 3 and 5
Patient Health Questionnaire-9 (PHQ-9)
Track the change in depression symptoms over a two-week period. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores indicate greater severity in depression symptoms.
Measured: Baseline (intake), weeks 3 and 5
Generalized Anxiety Disorder - 7 (GAD-7)
Track the change in anxiety symptoms over a two-week period. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21. Higher scores indicate greater severity in self-reported anxiety symptoms.
Measured: Baseline (intake), weeks 3 and 5
Secondary outcomes (3)
Satisfaction with Life Scale (SWLS)
A measure of satisfaction with one's life. 5 items are measured on a 7-point scale ranging from 1-7. Scores are summed to produce a total ranging from 5 to 35 with higher scores indicating greater satisfaction with one's life.
Measured: Baseline (intake), week 3 and 5
Feedback Questionnaire
A bespoke questionnaire consisting of 10 items with varying response formats measuring perceived treatment change and gathering feedback on likes and dislikes with the course. Items are not designed to be combined into a unitary measure. The questionnaire has been developed by the research team. A total score is not produced for this measure.
Measured: Week 3 and 5
Personalized Feedback Report Satisfaction Questionnaire
A bespoke 4-item questionnaire presented to clients randomized to the Feedback Group. The questionnaire uses a combination of various formats to assess clients' perception of the personalized feedback reports they received and their effectiveness. The questionnaire has been developed by the research team. A total score is not produced for this measure.
Measured: Week 3 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start11 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Macquarie University, Australia
- Responsible party
- Sponsor
- Investigators
- Heather Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806864
- Sponsor's protocol ID
- 2119
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants' de-identified research data will be stored in Borealis. Borealis is the University of Regina's official data repository. Data stored in this repository will be shared with authorized researchers and the research community, upon request, to advance science and health.
Publications
Powers JM, Zvolensky MJ, Ditre JW. An integrative review of personalized feedback interventions for pain and alcohol. Curr Opin Psychol. 2019 Dec;30:48-53. doi: 10.1016/j.copsyc.2019.01.013. Epub 2019 Jan 30.
PubMed 30825840Yang CM, Lu YL, Lee HC, Li S, Suh S, Okajima I, Huang YC. Can adding personalized rule-based feedback improve the therapeutic effect of self-help digital cognitive behavioral therapy for insomnia in young adults? Sleep Med. 2023 Jul;107:36-45. doi: 10.1016/j.sleep.2023.04.012. Epub 2023 Apr 14.
PubMed 37105069Sapkota RP, Gretton A, Wilhelms A, Bisby MA, Dear B, Titov N, Hadjistavropoulos HD. Feasibility trial of an unguided ultra-brief online psychological intervention within an online mental health clinic: The "things you do" intervention. Internet Interv. 2025 Jun 26;41:100852. doi: 10.1016/j.invent.2025.100852. eCollection 2025 Sep.
PubMed 40641667Bisby MA, Barrett V, Staples LG, Nielssen O, Dear BF, Titov N. Things You Do: A randomized controlled trial of an unguided ultra-brief intervention to reduce symptoms of depression and anxiety. J Anxiety Disord. 2024 Jul;105:102882. doi: 10.1016/j.janxdis.2024.102882. Epub 2024 May 27.
PubMed 38850775Bisby MA, Dear BF, Karin E, Fogliati R, Dudeney J, Ryan K, Fararoui A, Nielssen O, Staples LG, Kayrouz R, Cross S, Titov N. An open trial of the Things You Do Questionnaire: Changes in daily actions during internet-delivered treatment for depressive and anxiety symptoms. J Affect Disord. 2023 May 15;329:483-492. doi: 10.1016/j.jad.2023.02.117. Epub 2023 Mar 1.
PubMed 36863469
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Engagement and Effectiveness of the 'Things You Do' Program
- ClinicalTrials.gov ID
- NCT07806864
- Acronym / sponsor ID
- 2119
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, Personalized Feedback, Healthy Actions, Randomized Controlled Trial, Internet-delivered Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Macquarie University, Australia
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research shows that the single lesson 'Things You Do' Intervention is effective in increasing engagement in everyday healthy actions. However, no research has examined whether its effectiveness is enhanced by incorporating personalized feedback on participants' current level of engagement in healthy actions. In this randomized controlled trial, clients will be randomly assigned to either receive or not receive personalized feedback informing them of their level of engagement in healthy actions over the previous week and encouraging them to participate in more healthy activities. The investigators will examine whether this feedback increases engagement in healthy actions and enhances the effectiveness of the 'Things You Do' Intervention as assessed through changes in primary outcomes.
Detailed description
Individuals seeking psychological services for mental health concerns often face barriers to care, including long wait times, cost, stigma, time constraints, geographical limitations, and difficulty accessing culturally sensitive providers. To address these barriers, Internet-delivered Cognitive Behavioral Therapy (ICBT) has emerged as a scalable, cost-effective, and accessible alternative to face-to-face therapy for individuals experiencing depression and anxiety. ICBT typically involves the delivery of evidence-based cognitive behavioral therapy through online lesson modules over several weeks or months, often accompanied by therapist support through secure messaging and/or telephone calls. However, research suggests that clients are satisfied with and benefit from brief forms of ICBT that require little to no therapist involvement.
In Saskatchewan, the Online Therapy Unit provides ICBT as part of routine care for a range of mental health concerns. Recently, the Unit introduced the Things You Do (TYD) program, a brief ICBT intervention for depression and anxiety that serves as an alternative to the standard 8-week ICBT program. The TYD program consists of a single lesson designed to reduce symptoms of depression and anxiety and further encourages engagement in everyday healthy actions via daily messaging, referred to as the 'Things You Do'. These healthy actions are organized into five domains: healthy thinking, meaningful activities, goals and plans, healthy routines, and social connections. Research indicates that greater engagement in these healthy actions is associated with lower levels of depression and anxiety, as well as improved overall mental health and well-being. The feasibility, acceptability, and effectiveness of the TYD program in routine care have also yielded promising results in a previous study conducted within the OTU. For instance, the results from this study indicated a significant increase in each of the healthy actions over time. While increased engagement in healthy actions was associated with reductions in anxiety and depressive symptoms, there are still opportunities to improve outcomes by assessing the effects of further personalizing the intervention on the outcomes. Although the TYD program provides information and strategies to encourage engagement in healthy actions, providing participants with personalized feedback regarding their current level of engagement may further enhance behavior change.
Research has demonstrated that personalized feedback can increase individuals' awareness of their own behaviours, facilitate behaviour change in targeted areas, and contribute to improved outcomes. In addition, personalized feedback has been associated with greater treatment satisfaction. Although personalized feedback has demonstrated benefits in areas such as alcohol misuse and pain management, its potential to promote engagement in healthy actions associated with mental health and well-being has not yet been examined. Providing clients with personalized feedback may increase awareness of their areas of strength, identify opportunities for improvement, and offer suggestions for increasing engagement in healthy behaviours.
The objective of the current study is to examine whether providing personalized feedback based on participants' reported frequency of engaging in healthy actions would encourage greater participation in healthy actions and enhance engagement in the TYD program. Participants will complete outcome measures at screening, Week 3, and Week 5. Primary outcomes include symptoms of depression, symptoms of anxiety, and engagement in healthy actions.
Randomization
Clients within a naturalistic online ICBT clinic eligible for the TYD program will be randomly assigned in a 1:1 ratio, using the REDCap randomization module, to either receive the standard TYD program or the standard program plus personalized feedback. The personalized feedback reports, developed using participants' responses to the Things You Do Questionnaire (TYDQ-15), are intended to increase awareness of areas of strength, identify areas for improvement, and provide suggestions for increasing engagement in healthy actions. Clients assigned to the personalized feedback condition will receive feedback at screening, in Week 3, and in Week 5 following completion of the TYDQ-15 at each assessment point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT Without Personalized Feedback | Active comparator | Behavioral: Things You Do Program (Ultra-Brief ICBT)At intake, clients eligible for the Things You Do (TYD) program will be randomly assigned (1:1 ratio) to either the Feedback Group or the No Feedback Group following completion of the demographic questionnaire, which includes the 15-item Things You Do Questionnaire. Clients will be automatically randomized using the Research Electronic Data Capture (REDCap) automated randomization module. Clients randomized to the No Feedback Group will receive the standard TYD intervention. All clients will complete the standardized questionnaires again in Weeks 3 and 5 following enrollments in the program. |
| ICBT With Personalized Feedback | Experimental | Behavioral: Things You Do Program Plus Personalized FeedbackClients randomly assigned to the Feedback Group will receive the standard Things You Do (TYD) program as well as a personalized feedback report at intake, in Week 3, and in Week 5 following the completion of questionnaires at each of these time points. These personalized feedback reports are generated based on clients' scores on the Things You Do Questionnaire at each assessment time point. The reports are designed to inform clients of their level of engagement in healthy actions across the five areas of healthy actions. The reports highlight areas of strength and areas for improvement and provide encouragement and practical suggestions for increasing engagement in the areas in which clients reported the lowest levels of engagement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Canadian resident;
- Aged 18 years or older;
- Access to a computer (or another appropriate device) and the Internet;
- Willingness to learn information and skills to self-manage mental health difficulties.
Key exclusion criteria (1 listed)
- Unable to read and understand English (All content is provided in English ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Things You Do Program (Ultra-Brief ICBT)The TYD program is an ultra-brief ICBT intervention developed at Macquarie University, Australia. The intervention provides psychoeducation on mental health and five areas of healthy actions, known as the "Things You Do," along with practical skills to support engagement in these actions. These five areas include Meaningful Activities, Healthy Thinking, Goals and Plans, Healthy Habits, and Social Connections. The intervention includes a single lesson, a Weekly Planner, an Activity Guide, and a daily 'Tip of the Day' Offered for 30 days. The lesson content is presented across 25 slides using text and infographics and requires approximately 30-60 minutes to review. A key component of the TYD intervention is the daily 'Tip of the Day.' These are daily messages that clients receive for 30 days following the start of the intervention. Each message provides a tip or suggests a healthy action that clients can engage in that day. Clients complete the program without therapist support. | Behavioural | ICBT Without Personalized Feedback |
| Things You Do Program Plus Personalized FeedbackParticipants in this arm receive the same Things You Do (TYD) intervention as those in the comparative arm, with the addition of personalized feedback report. The TYD program is an ultra-brief ICBT intervention providing psychoeducation on mental health and five areas of healthy actions: Meaningful Activities, Healthy Thinking, Goals and Plans, Healthy Habits, and Social Connections. The intervention includes a single lesson (25 slides), Weekly Planner, Activity Guide, and daily "Tip of the Day" delivered for 30 days following enrollment in the intervention. Participants complete the intervention independently without therapist support. In addition to the standard TYD intervention, participants in this arm receive a personalized feedback report at screening, in Week 3, and in Week 5 following enrollment. Reports provide individualized feedback on participants' engagement across the five areas of healthy actions and are intended to encourage and motivate engagement in these areas. | Behavioural | ICBT With Personalized Feedback |
Primary outcome
Things You Do-15 (TYD-15)
Time frame: Baseline (intake), week 3 and 5
A measure of engagement in healthy actions over the previous week. 15 items are measured on a 5-point Likert scale ranging from 0-4. Subscales include Routine, Thoughts, Social, Activity, and Goals. Scores are summed into subscale scores ranging from 0 to 12, with a total score ranging from 0 to 60. Higher scores on this measure indicate greater engagement in healthy actions.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (intake), weeks 3 and 5
Track the change in depression symptoms over a two-week period. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores indicate greater severity in depression symptoms.
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Baseline (intake), weeks 3 and 5
Track the change in anxiety symptoms over a two-week period. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21. Higher scores indicate greater severity in self-reported anxiety symptoms.
3 secondary outcomes
Satisfaction with Life Scale (SWLS)
Time frame: Baseline (intake), week 3 and 5
Feedback Questionnaire
Time frame: Week 3 and 5
Personalized Feedback Report Satisfaction Questionnaire
Time frame: Week 3 and 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Results publication: PubMed 30825840Powers JM, Zvolensky MJ, Ditre JW. An integrative review of personalized feedback interventions for pain and alcohol. Curr Opin Psychol. 2019 Dec;30:48-53. doi: 10.1016/j.copsyc.2019.01.013. Epub 2019 Jan 30.
- Results publication: PubMed 37105069Yang CM, Lu YL, Lee HC, Li S, Suh S, Okajima I, Huang YC. Can adding personalized rule-based feedback improve the therapeutic effect of self-help digital cognitive behavioral therapy for insomnia in young adults? Sleep Med. 2023 Jul;107:36-45. doi: 10.1016/j.sleep.2023.04.012. Epub 2023 Apr 14.
- Results publication: PubMed 40641667Sapkota RP, Gretton A, Wilhelms A, Bisby MA, Dear B, Titov N, Hadjistavropoulos HD. Feasibility trial of an unguided ultra-brief online psychological intervention within an online mental health clinic: The "things you do" intervention. Internet Interv. 2025 Jun 26;41:100852. doi: 10.1016/j.invent.2025.100852. eCollection 2025 Sep.
- Results publication: PubMed 38850775Bisby MA, Barrett V, Staples LG, Nielssen O, Dear BF, Titov N. Things You Do: A randomized controlled trial of an unguided ultra-brief intervention to reduce symptoms of depression and anxiety. J Anxiety Disord. 2024 Jul;105:102882. doi: 10.1016/j.janxdis.2024.102882. Epub 2024 May 27.
- Results publication: PubMed 36863469Bisby MA, Dear BF, Karin E, Fogliati R, Dudeney J, Ryan K, Fararoui A, Nielssen O, Staples LG, Kayrouz R, Cross S, Titov N. An open trial of the Things You Do Questionnaire: Changes in daily actions during internet-delivered treatment for depressive and anxiety symptoms. J Affect Disord. 2023 May 15;329:483-492. doi: 10.1016/j.jad.2023.02.117. Epub 2023 Mar 1.
- Individual participant dataSharing planned: Undecided. Participants' de-identified research data will be stored in Borealis. Borealis is the University of Regina's official data repository. Data stored in this repository will be shared with authorized researchers and the research community, upon request, to advance science and health.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Hadjistavropoulos, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Things You Do Program (Ultra-Brief ICBT) and Things You Do Program Plus Personalized Feedback in people with Depression and Anxiety, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcie Nugent (306-337-3331, marcie.nugent@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Things You Do-15 (TYD-15) (time frame: Baseline (intake), week 3 and 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07806864, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.